GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs. We are currently hiring for a CQV Engineer for our Sligo based client.

CQV Engineer

Key Responsibilities:

• • Commissioning & Qualification of new aseptic manufacturing equipment
  • Writing and execution of qualification documentations such as: FAT, SAT, IOQ, PQ protocols
  • Provide Support for the development of URS and Functional Specification associated with asepctic processing
  • Provide technical assistance during investigations or process/equipment
  • Ensures on-time execution of the schedule and reports
  • Ensures Periodic Review plans are completed per site & regulatory requirements
  • Collaborates with various departments/teams in development and execution of validation activities associated with new equipment/product introductions and process improvements.
  • Ensures validation activities are managed in conjunction with all company and regulatory requirements (Health & Safety, cGMP, construction, environmental etc.).
  • Provide change control assessments which could impact the validated state of process equipment.
  • Leading Risk assessments, root cause analysis and investigations as applicable.
  • Own departmental SOPs and ensure they follow corporate standards and applicable regulations

  Equipment:

  Single Use Equipment, Mobile Equipment – SUM/TCU/Utility Panels/Reactor Facility Qualification

  OR

  Fine Line (Vial / Syringe ) / Lyo /Capper / External Vial Washer

  Qualifications

  • Previous experience in execution of asepctic equipment/qualification/asepctic processing
  • Advanced knowledge of FAT, SAT, IOQ
  • Risk – based verification
  • Previous experience on Kneat/online validation package

We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated CQV Specialist seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.